Wellness and prevention could play a bigger role in the health care reform debate as supplement industry champion Sen. Tom Harkin takes the helm of the Senate Health, Education, Labor and Pensions Committee.

Harkin announced Sept. 9 he will be chairman of HELP, the committee with jurisdiction over FDA and other Department of Health and Human Services agencies.

The Iowa Democrat will leave the Agriculture, Nutrition and Forestry Committee chair for the HELP post left vacant by the death of Sen. Ted Kennedy Aug. 25 (¹ Also see "Loss Of Sen. Kennedy Leaves Hole In HELP Committee, FDA Oversight" - Pink Sheet, 31 August, 2009.).

Dietary supplement industry stakeholders may breathe easier knowing an industry champion is taking the leading role on HELP. Harkin has said he will defend the Dietary Supplement Health and Education Act against amendments that could put greater restrictions on products (² Also see "Sen. Harkin Defends DSHEA, Promotes Supplements In Health Legislation" - Pink Sheet, 20 July, 2009.).

Sen. Chris Dodd, D-Conn., who chairs the Banking, Housing and Urban Affairs Committee, was next in line for the HELP chair. He had substituted for Kennedy since June, but announced Sept. 9 he will remain in his Banking seat. As second in seniority on the committee, Harkin was next up for the spot.

Harkin said Dodd still will play a leading role in pushing for health reform and passage of the Affordable Health Choices Act of 2009. Dodd led the Health Committee markup of the bill. "He started it, he spent a lot of time on it, he should finish it," Harkin said.

Harkin pushed for the bill to establish community-based demonstration projects to measure the health benefits and cost savings associated with calcium plus vitamin D, folic acid and fish oil supplementation (see story p. 14).

Dodd also shepherded through committee Kennedy's bill to give FDA regulatory authority for tobacco products, which is now law (³ Also see "Tight 90-Day Countdown To Create Tobacco Center Poses Challenge To FDA" - Pink Sheet, 15 June, 2009.).

Supplements Champion

Harkin's support for the supplement industry is widely known. Along with Utah Republican Sen. Orrin Hatch he cosponsored DSHEA in 1994.

Patricia Knight, who served as chief of staff for Hatch and was his lead health staffer for DSHEA, said Harkin's position likely will "help make certain that its intent is preserved."

Knight is currently a lobbyist with her own consulting firm, Washington-based Knight Capitol Consultants. She also recently began representing the United Natural Products Association.

She said Harkin's elevation gives the supplement industry a more secure buffer against House Energy and Commerce Chairman Rep. Henry Waxman, D-Calif., who frequently has called for amending DSHEA to more stringently regulate the industry.

Waxman published a book in 2009, "The Waxman Report," which calls DSHEA "every bit as harmful as we feared, demonstrating anew that any market lacking regulation or the need to ensure safety quickly sinks to the lowest common denominator."

Knight said, "It's fair to say that the dietary supplement industry can be expected to find a more friendly advocate for its issues with Chairman Harkin."

She noted Harkin also has supported stringent enforcement of regulations, working "to beef up FDA funding for supplement enforcement to remove the bad actors from the market."

For example, he was a cosponsor on the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, which requires supplement products and OTCs to carry adverse event reporting information (⁴ Also see "Adverse Event Bill Down To The Wire As Congress Wraps Up" - Pink Sheet, 11 December, 2006.).

Hatch and Harkin both pushed FDA for years to develop good manufacturing practices for dietary supplements, as authorized by DSHEA. A phased-in rollout of GMPs began in June 2008 and will finish in June 2010.

Harkin also supports allowing food stamp eligibility for certain supplements. He unsuccessfully supported legislation via the Agriculture Committee to make the change in the previous two reauthorizations of the federal farm subsidy programs (⁵ Also see "Vitamins, Supplements Added To Food Stamp Program In Senate Farm Bill" - Pink Sheet, 29 October, 2007.).

The five-term senator had a hand in establishing the National Center for Complementary and Alternative Medicine, and the Office of Dietary Supplements at the National Institutes of Health.

"He has a personal and long-held, deep interest and commitment to prevention and wellness, especially recognizing the benefits of dietary supplements. So it would be natural to assume he'd place it as a priority as chairman of the HELP Committee," Knight said.

Harkin also backs more funding for biomedical research. He pushed for an additional $10 billion for NIH via the economic stimulus package.

Harkin's staff said he will continue as chairman of the Senate Appropriations subcommittee with Labor, Education and HHS oversight. The subcommittee has oversight of all HHS agencies except FDA, which is under the Agriculture subcommittee.

Competing Priorities

Daniel Fabricant, acting executive director of the Natural Products Association, said Harkin has "always looked at prevention." As HELP chairman, Harkin "really will reinvigorate the prevention aspects of health care reform," Fabricant said in an interview.

While Fabricant acknowledged he does not expect Harkin to bring an "all supplements, all the time" focus to HELP, he said he would likely foster more nutrition-based discussion.

The member in the chairman's seat also "tends to have people's ears a little longer than" other members, and therefore can promote his agenda more directly, Fabricant noted.

Mike Greene, senior director of government relations with the Council for Responsible Nutrition, who worked with Harkin as a congressional staffer, said the senator's pro-supplement history bodes well for the industry, but noted that HELP Committee chairs have many competing priorities.

"He's been very helpful to our industry in the past. We believe he'll be helpful in the future," Greene said. "We also know that being in charge of a committee this large he'll have his hands full with a lot of issues."

"I don't know that there will be much change initially," he said. "I think they will be more focused on the process of working through the health care reform bill and trying their best to move whatever vehicle they have to fruition."

The Consumer Healthcare Products Association said it admires Harkin "for his long-standing interest in and commitment to prevention and wellness, including his support of nutritional supplements."

Food Safety Bill To Move

During his announcement, Harkin noted one priority of his will be moving food safety legislation. The House June 30 passed its Food Safety Enhancement Act, H.R. 2749, which contains user fees for food manufacturers to help fund the bill's activities (⁶ Also see "House Passes Food Safety Bill That May Not Be Appetizing To Senate" - Pink Sheet, 3 August, 2009.).

Sen. Dick Durbin, D-Ill., introduced the Food Safety Modernization Act, S. 510, early 2009. Durbin's bill contains similar provisions to those in the House bill, but employs targeted fees as opposed to standard user fees. Durbin has said a bill with user fees will pass the Senate.

HELP Committee staffers expect Durbin's bill to serve as the vehicle for food safety legislation in the Senate.

While serving as Agriculture chairman, Harkin said salmonella-contaminated peanut butter illustrated that food GMPs need updating and a "gaping loophole" in the food safety system allows firms to avoid reporting contamination when products are not distributed (⁷ Also see "Salmonella Outbreak Reveals “Gaping Loophole” In Food GMPs – Sen. Harkin" - Pink Sheet, 9 February, 2009.).

Harkin will remain a member of Agriculture, where Sen. Blanche Lincoln, D-Ark., will succeed him as chair.

Despite Harkin's affinity for agriculture and its importance in his state, the HELP position likely appealed more because it offers more legislative action over the next several years; reauthorization of the federal farm subsidies program is not expected until 2013, while health care reform is Congress' current overriding agenda item.

- Katie Stevenson ( ⁸ k.stevenson@elsevier.com )

With Harkin As HELP Chair, Long-Time Supplement Ally Gains Ground

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